SENETEK LICENSES INVICORP® ERECTILE DYSFUNCTION
TREATMENT TO ARDANA FOR EUROPE
ARDANA TO ASSUME FULL REGULATORY RESPONSIBILITY
AND SENETEK TO RECEIVE ROYALTIES AND MILESTONE PAYMENTS
NAPA, Calif., and Edinburgh, UK 21 June, 2004 / PR Newswire-First
Call/ -- Senetek PLC (Nasdaq: SNTK), a healthcare technologies
company focused on developing and co-marketing products for the
anti-aging markets worldwide, and Ardana, the emerging pharmaceutical
company dedicated to improving reproductive health, today announced
the signing of an exclusive license for Ardana to manufacture
and market Invicorp®, Senetek's patented combination drug
treatment for male erectile dysfunction, in the European Union
and European Free Trade Area.
Under the license agreement, Ardana assumes full responsibility
for completing the European drug regulatory process for Invicorp®
and seeking national marketing approvals throughout Europe. Senetek
will receive royalties based on net sales of Invicorp® plus
milestone payments upon regulatory approvals in specified major
markets and achievement of specified cumulative net sales in Europe.
Invicorp® has been approved in Denmark, which has been chosen
as the Reference Member State for the Mutual Recognition Procedure
in Europe. Additionally, Invicorp® has been approved in New
Zealand where it will be marketed by another Senetek licensee
commencing later this month.
Current pharmacotherapy for erectile dysfunction includes oral,
transurethral and injectable intracavernosal treatments. The non-oral
erectile dysfunction market was estimated as $85 million worldwide
in 2003, with $45 million sales in Europe and $32 million in the
US (Source: IMS MAT Sept 03). Invicorp® is an injectable form
of phentolamine mesilate and vasoactive intestinal polypeptide.
Frank J. Massino, Chairman and Chief Executive Officer of Senetek,
commented, "Finding the right commercial partner for this
unique injectable formulation, with the focus it deserves and
the technical expertise and financial capability to speed it to
market, was a key objective of Senetek's 2004 business plan, and
Ardana is perfectly suited to that role. We are confident that
our partnership with Ardana will allow Invicorp® to realize
its full potential in the growing European erectile dysfunction
market. With this agreement in place, Senetek is ideally positioned
to concentrate on its core business of expanding its portfolio
of proprietary dermatologicals for the global ethical pharmaceutical
and cosmeceutical markets."
Dr. Maureen Lindsay, Chief Executive of Edinburgh-based Ardana,
said, "Some patients are unsuited to an oral formulation
and we believe the market for injectable treatments for erectile
dysfunction will grow as awareness of the condition increases.
Based on clinical data we also believe that Invicorp® can
provide important benefits in the injectable treatment of erectile
dysfunction. Invicorp®, together with Striant(TM) SR, our
testosterone replacement therapy for men with primary or secondary
hypogonadism, which we recently launched in the UK, provide the
basis for developing our franchise in male reproductive health,
one of the areas we are focusing on through our specialist sales
force. This deal represents the next milestone in our development
as we build a portfolio of revenue generating products to take
us through to profitability."
Senetek PLC is a life sciences-driven product development and
licensing company focused on the high growth market for dermatological
and skin care products primarily addressing photodamage and age-related
skin conditions. Senetek's patented compound Kinetin is a naturally
occurring cytokinin that has proven effective in improving the
appearance of aging skin with virtually none of the side effects
associated with acid-based active ingredients. Senetek has licensed
Kinetin to leading global and regional dermatological and skin
care marketers including Valeant Pharmaceuticals, The Body Shop
and Revlon, and recently announced the grant to Valeant Pharmaceuticals
of rights to license Zeatin, a promising analogue of Kinetin currently
in pre-clinical trials. Senetek's researchers at the University
of Aarhus, Denmark, also are collaborating with the Institute
of Experimental Botany, Prague, and with Beiersdorf AG, Hamburg,
to identify and evaluate additional new biologically active compounds
for this high growth field. www.senetekplc.com
Senetek PLC Investor Relations Contact:
1-707-226-3900 ext. 102
E-mail: Pknopick@eandecommunications.com
Ardana Limited is an emerging pharmaceutical company focused
on reproductive health. It aims to become a leading source of
clinical and commercial innovation in the $20 billion human reproductive
health market, which is growing at 9% per annum. In addition to
Striant™ SR, Ardana has a rich development portfolio including
the Gonadotrophin Releasing Hormone (GnRH)-antagonist, Teverelix
LA, in Phase II trials in patients with prostate cancer and benign
prostate hyperplasia, Chronodyne® (terbutaline) which is in
Phase I/II trials for endometriosis-related infertility (being
developed in collaboration with Columbia Laboratories (NASDAQ:
CBRX) and a reformulation of the GnRH analog 'Leuprorelin' which
is in Phase II trials for prostate cancer. www.ardana.co.uk
Ardana's therapeutic interests encompass androgen replacement,
infertility, sexual dysfunction and obstetrics. The company has
exclusive rights to commercialise research by the Medical Research
Council (MRC)'s Human Reproductive Sciences Unit (HRSU) in Edinburgh,
Scotland, which has been at the forefront of this area of research
for the last 30 years. The HRSU contributes a plethora of early
stage development compounds to the Ardana development portfolio,
which complement later stage and marketed products. The MRC employs
nearly 100 staff at the Unit, which currently receives total annual
funding of £3.8 million.
Ardana has raised £43.4 million in four funding rounds.
Ardana investors include DVC Deutsche Venture Capital, Albany
Venture Managers Limited and 3i Bioscience Investment Trust, Merlin
Biosciences Limited, MVM Limited (MVM), Techno Venture Management
(TVM), ABN-AMRO Participates, 3i Group plc, ISIS Equity Partners
plc, Scottish Widows Investment Partnership Ltd, Saffron Hill
Ventures, Mitsubishi Corporation and Green Highlander, LLC.
For more information please contact:
Maureen Lindsay, Ardana 44 (0)131 226 8550
Julia Phillips / Francetta Carr, Financial Dynamics (corporate
and financial media relations) 44 (0)20 7831 3113
Nicki Brimicombe (trade and technical media
relations), NB Public Relations
44 (0)1883 732353
Safe Harbor Statement
This news release contains statements that may be considered
"forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act, including those that
might imply Senetek's expectation that that Invicorp® will
receive regulatory approvals in Europe for its marketing, and
that Ardana Ltd. will achieve commercial success with this product.
Forward-looking statements by their nature involve substantial
uncertainty, and actual results may differ materially from those
that might be suggested by such statements. Important factors
identified by the Company that it believes could result in such
material differences are described in the Company's Annual Report
on Form 10-K for the year 2003. However, the Company necessarily
can give no assurance that it has identified or will identify
all of the factors that may result in any particular forward-looking
statement materially differing from actual results, and the Company
assumes no obligation to correct or update any forward-looking
statements which may prove to be inaccurate, whether as a result
of new information, future events or otherwise.
back to top
|
|
